WALTHAM, MA -- July 9, 2007 -- OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN) a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced that it has begun a pivotal registration study of its first-in-class vascular disrupting agent, ZYBRESTAT(TM) (combretastatin-A4 phosphate / CA4P), in patients with metastatic anaplastic thyroid cancer (ATC).
The multinational, randomized and controlled, Phase II/III study is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA) and is expected to enroll approximately 180 patients at about 45 sites in the United States, Eastern and Western Europe, Asia, and the Middle East. Two-thirds of the patients will be administered intravenous ZYBRESTAT plus carboplatin and paclitaxel, and the other third will receive carboplatin and paclitaxel alone. The primary endpoint will be a statistically significant difference in the overall survival rate between the two treatment arms, as determined by a log-rank analysis of Kaplan-Meier survival curves at times when pre-determined numbers of study events (patient deaths) are reached. The study design incorporates a planned interim analysis for efficacy and safety, which will be overseen by an Independent Data Monitoring Committee. ZYBRESTAT has been granted Fast Track status by the FDA and Orphan Drug status by both the FDA and the European Agency for the Evaluation of Medicinal Products (EMEA).
"The initiation of this pivotal study last week represents a major advancement in the Company's efforts to bring ZYBRESTAT to market," said Richard Chin, M.D., Chief Executive Officer of OXiGENE. "There is a tremendous need for effective treatment options for patients suffering from anaplastic thyroid cancer, and this pivotal registration study is based on a significant body of encouraging preclinical and clinical data that suggest that the combination of ZYBRESTAT, carboplatin, and paclitaxel has activity against anaplastic thyroid cancer and other solid tumors."
Additional information regarding the study design, enrollment criteria, and participating centers will be available at http://www.clinicaltrials.gov (keyword: anaplastic thyroid cancer).
About Anaplastic Thyroid Cancer
ATC is one of the most lethal cancers known in humans. There are no approved treatments for this disease. ATC is a high-grade neoplasm, characterized by an aggressive clinical course with brief survival, and refractoriness to currently available local and systemic modalities of treatment. ATC comprises 1-2% of all thyroid malignancies in the United States, and up to 5% in certain countries outside the United States. While ATC epidemiology has not been extensively studied and documented, it is estimated that there are approximately 1,000 to 4,000 new cases per year in the U.S. and in Europe combined. Newly-diagnosed ATC patients have a median life expectancy of approximately 3 months, and only a very limited number of patients survive for longer than one year.
About ZYBRESTAT / Combretastatin A4P (CA4P)
The Company believes that ZYBRESTAT is poised to become the first therapeutic product in a novel class of small-molecule drug candidates called vascular disrupting agents (VDAs). Through interaction with vascular endothelial cell cytoskeletal proteins, ZYBRESTAT selectively targets and collapses tumor vasculature, thereby depriving the tumor of oxygen and causing death of tumor cells. ZYBRESTAT has demonstrated potent and selective activity against tumor vasculature, as well as clinical activity against ATC and other solid tumors in clinical studies.
About Special Protocol Assessments
A Special Protocol Assessment (SPA) is an agreement with the U.S. Food and Drug Administration that the Company's Phase II/III clinical trial design is sufficient to form the basis for a regulatory approval, if pre-specified efficacy results are achieved. The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of a New Drug Application (NDA). For more information on Special Protocol Assessments, please go to http://www.fda.gov/cber/gdlns/protocol.htm#ii.
About OXiGENE, Inc.
OXiGENE is a clinical-stage biopharmaceutical company developing novel small- molecule therapeutics to treat cancer and eye diseases. The Company's major focus is the clinical advancement of drug candidates that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property position and therapeutic development expertise to bring life-saving and life-enhancing medicines to patients.
Safe Harbor Statement
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release, including those relating to the successful completion of the planned Phase II/III trial, approval by the FDA, timing of patient enrollment, and ZYBRESTAT leading a novel class of small-molecule drug candidates may turn out to be wrong. Forward-looking statements can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's Form 10-K, 10-Q and 8-K reports. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2006.
Information for Patients and Caregivers
If you are a patient or a caregiver, and you would like further information about enrollment in the ATC and the OXiGENE Pivotal ZYBRESTAT clinical trial, please contact ThyCa, Thyroid Cancer Survivors' Association, Inc.:
ThyCA www.ThyCa.org (877) 588-7904 [email protected]
CONTACT: OXiGENE, Inc. Investor Relations 781-547-5900